GUDID 00840682125840

GE HEALTHCARE JAPAN CORPORATION

Nonimplantable needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable

• Primary Device ID: 00840682125840
• NIH Device Record Key: 06b9681e-872c-4486-bfc3-7ea4630b20bc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: E8C Reusable Guide Attachment
• Company DUNS: 696021596
• Company Name: GE HEALTHCARE JAPAN CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682125840 [Primary]

FDA Product Code

• MJG: DEVICE, PERCUTANEOUS, BIOPSY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-11-15

Devices Manufactured by GE HEALTHCARE JAPAN CORPORATION

• 00195278620453 - DLIR: 2023-07-10 SWMD DLIR Application for Smart Subscription
• 00195278303196 - ASiR-V: 2021-09-02 ASiR-V Application Container for Smart Subscription
• 00195278303202 - DLIR: 2021-09-02 DLIR Application Container for Smart Subscription
• 00195278303219 - MAR: 2021-09-02 MAR Application Container for Smart Subscription
• 00840682146173 - Revolution: 2020-12-04 NGX Gantry common top asm with UDI
• 00840682110181 - NA: 2020-05-05
• 00840682146586 - DLIR: 2020-03-02
• 00840682125826 - NA: 2019-12-23